@article {1366, title = {Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial.}, journal = {JAMA}, volume = {331}, year = {2024}, month = {2024 Feb 13}, pages = {482-490}, abstract = {

IMPORTANCE: Repeated mass distribution of azithromycin has been shown to reduce childhood mortality by 14\% in sub-Saharan Africa. However, the estimated effect varied by location, suggesting that the intervention may not be effective in different geographical areas, time periods, or conditions.

OBJECTIVE: To evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention.

DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized placebo-controlled trial evaluating the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality included 341 communities in the Nouna district in rural northwestern Burkina Faso. Participants were children aged 1 to 59 months living in the study communities.

INTERVENTIONS: Communities were randomized in a 1:1 ratio to receive oral azithromycin or placebo distribution. Children aged 1 to 59 months were offered single-dose treatment twice yearly for 3 years (6 distributions) from August 2019 to February 2023.

MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census.

RESULTS: A total of 34 399 children (mean [SD] age, 25.2 [18] months) in the azithromycin group and 33 847 children (mean [SD] age, 25.6 [18] months) in the placebo group were included. A mean (SD) of 90.1\% (16.0\%) of the censused children received the scheduled study drug in the azithromycin group and 89.8\% (17.1\%) received the scheduled study drug in the placebo group. In the azithromycin group, 498 deaths were recorded over 60 592 person-years (8.2 deaths/1000 person-years). In the placebo group, 588 deaths were recorded over 58 547 person-years (10.0 deaths/1000 person-years). The incidence rate ratio for mortality was 0.82 (95\% CI, 0.67-1.02; P = .07) in the azithromycin group compared with the placebo group. The incidence rate ratio was 0.99 (95\% CI, 0.72-1.36) in those aged 1 to 11 months, 0.92 (95\% CI, 0.67-1.27) in those aged 12 to 23 months, and 0.73 (95\% CI, 0.57-0.94) in those aged 24 to 59 months.

CONCLUSIONS AND RELEVANCE: Mortality in children (aged 1-59 months) was lower with biannual mass azithromycin distribution in a setting in which seasonal malaria chemoprevention was also being distributed, but the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03676764.

}, issn = {1538-3598}, doi = {10.1001/jama.2023.27393}, author = {Oldenburg, Catherine E and Ouattara, Mamadou and Bountogo, Mamadou and Boudo, Valentin and Ouedraogo, Thierry and Compaor{\'e}, Guillaume and Dah, Clarisse and Zakane, Alphonse and Coulibaly, Boubacar and Bagagnan, Cheik and Hu, Huiyu and O{\textquoteright}Brien, Kieran S and Nyatigo, Fanice and Keenan, Jeremy D and Doan, Thuy and Porco, Travis C and Arnold, Benjamin F and Lebas, Elodie and Sie, Ali and Lietman, Thomas M} }